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Despite a rapidly increasing number of renal denervation (RDN) procedures, only little is known regarding the patient or procedural characteristics influencing the outcome. None of the detectable variables like number of ablation points, temperature rise, impedance drop, have been shown to correlate with the blood pressure (BP) reduction. In this study, the investigators assess different patient and procedural characteristics, like exact patient medication, stress hormones, heart rate variability, and focus on the change of the catecholamine spill-over, and the impact on BP and heart rate after RDN and after EP ablation. The investigators hypothesize the correlation between reduction of catecholamine spill-over due to denervation and the BP reduction. In this study, the investigators will assess 40 patients undergoing RDN and 40 patients undergoing EP ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal denervation (RDN) | Change of catecholamine spill-over during RDN | ||
| Electrophysiology (EP) Ablation | Change of catecholamine spill-over during EP ablation |
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| Measure | Description | Time Frame |
|---|---|---|
| Catecholamine norepinephrine and epinephrine (pg/ml) | Measurement the differences of norepinephrine and epinephrine (pg/ml) in the renal vein and artery before and after the ablation | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the ablation on 24-hour blood pressure (mmHg) and heart rate (beats/min) | Complete measurement of 24-hour systolic, diastolic, and mean arterial blood pressure (mmHg) and heart rate (beats/min)before and after ablation | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing renal denervation or EP Ablation with informed consent fulfilling all inclusion criteria and None of the exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klaus A Tiroch, MD | Contact | +49-202-896-5698 | klaus.tiroch@helios-kliniken.de | |
| Jacek Szymanski, MD | Contact | +49-202-896-5377 | jacek.szymanski@helios-kliniken.de |
| Name | Affiliation | Role |
|---|---|---|
| Klaus A Tiroch, MD | University Wittn/Herdecke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HELIOS Klinikum | Recruiting | Wuppertal | North Rhine-Westphalia | 42117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21403086 | Background | Symplicity HTN-1 Investigators. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011 May;57(5):911-7. doi: 10.1161/HYPERTENSIONAHA.110.163014. Epub 2011 Mar 14. | |
| 21093036 | Background | Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Blood for measurement of catecholamines.
| 19710497 | Result | Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med. 2009 Aug 27;361(9):932-4. doi: 10.1056/NEJMc0904179. No abstract available. |
| 26603990 | Derived | Tiroch K, Sause A, Szymanski J, Nover I, Leischik R, Mann JF, Vorpahl M, Seyfarth M. Intraprocedural reduction of the veno-arterial norepinephrine gradient correlates with blood pressure response after renal denervation. EuroIntervention. 2015 Nov;11(7):824-34. doi: 10.4244/EIJV11I7A167. |